| Primary Device ID | 07613252133544 |
| NIH Device Record Key | f71ae358-8b6e-4327-bcc3-d331c4847e85 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5444-0-200 |
| Catalog Number | 5444-0-200 |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613252133544 [Primary] |
| KKY | MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
| 07613327602708 - MDM X3 Insert | 2024-06-21 X3 Insert for MDM Liner |
| 07613327602715 - Biolox | 2024-06-21 Ceramic V40 Femoral Head |
| 04546540273376 - Orthinox | 2024-06-06 V40 FEM HEAD |
| 07613327602722 - Biolox | 2024-06-05 Ceramic V40 Femoral Head |
| 07613327605471 - INSTRUMENT | 2024-06-05 MDM MONOPOLAR TRIAL INSERT |
| 07613327564815 - INSTRUMENT | 2024-03-21 Exeter X3 RimFit Cups Template (7309) |
| 07613327565874 - INSTRUMENT | 2024-03-21 Restoration Modular Revision Hip System - Conical Distal Stem (Straight) 115mm Template |
| 07613327404876 - INSTRUMENT | 2023-11-10 Triathlon Pro Femoral Trial |